The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Aarhus, Denmark
Maternal glycemic variability (GV)
The Coefficient of Variation, power: n = 50
Time frame: 24 hours
Maternal glycemic variability (GV)
Interquartile range (IQR), power n = 40
Time frame: 24 hours
Maternal glycemic variability (GV)
Standard deviation (SD), power n = 18
Time frame: 24 hours
24 hours interstitial fluid glucose measures
Continuous glucose monitoring
Time frame: 24 hours
mean glucose
Continuous glucose monitoring
Time frame: 24 hours
maximum glucose
Continuous glucose monitoring
Time frame: 24 hours
Interstitial fluid glucose concentrations
Continuous glucose monitoring
Time frame: 3 hours following breakfast
Total energy expenditure
Measured with a combined accelerometer and heart rate monitor, reported in kcal
Time frame: 24 hours
Activity energy expenditure
Measured with a combined accelerometer and heart rate monitor, reported in kcal
Time frame: 24 hours
Activity count
Measured with a combined accelerometer and heart rate monitor, reported in counts
Time frame: 24 hours
Heart rate
Measured with a combined accelerometer and heart rate monitor, reported in beats per minute
Time frame: 24 hours
Resting energy expenditure (REE) (Resting Metabolic Rate)
Indirect calorimetry
Time frame: Performed for 20 minutes
Respiratory quotient (RQ)
Indirect calorimetry
Time frame: Performed for 20 minutes
Oxidation rates of lipid, carbohydrate and protein
Indirect calorimetry
Time frame: Performed for 20 minutes
Diet diary
Total energy intake, composition of macronutrients
Time frame: 24 hours
Self-reported appetite
Questionnaire: A numerical rating scale ranging from "not at all = 0" to "extremely = 10" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).
Time frame: 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36
Body Mass Index
weight and height will be combined to report BMI in kg/m\^2
Time frame: at diagnosis, week 32 and week 36
Gestational weight change
Time frame: at diagnosis, week 32 and week 36
Medications
number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure)
Time frame: from diagnosis to delivery
Pregnancy data
Number of participants with hypertension, preeclampsia, maternal weight gain
Time frame: from diagnosis to delivery
Delivery data
Number of patients with cesarean section, shoulder dystocia, induction of labour
Time frame: at delivery
Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance
Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey
Time frame: Day 1 postpartum
Blood pressure
Systolic and diastolic blood pressure
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Insulin like growth factor I (IGF-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in FGF-21 (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Leptin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Adiponectin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in CRP (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Prolactin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Cortisol (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Insulin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Free Fatty Acids (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in lactate (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in grehlin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucose independent peptide (GIP) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucagon like peptide 1 (GLP-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucagon (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in c-peptide (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in amino acids (AA) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in progesterone (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in steroid hormone binding protein (SHBP) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in osteocalcin (OCN) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Human chorionic gonadotropin (HCG) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in CD163 (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in estradiol (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in hb1ac (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in lipids (cholesterol, triglyceride) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Insulin (cord blood, offspring)
Time frame: at delivery
Concentration differences in c-peptide (cord blood, offspring)
Time frame: at delivery
Concentration differences in glucagon (cord blood, offspring)
Time frame: at delivery
Concentration differences in glucose (cord blood, offspring)
Time frame: at delivery
Concentration differences in lactate (cord blood, offspring)
Time frame: at delivery
Differences in pH (cord blood, offspring)
Measurement of acidity of the blood. Standard measurement performed on a sample of cord blood when a baby is delivered to evaluate possible oxygen deficiency during delivery.
Time frame: at delivery
non-targeted metabolomics analysis (cord blood, offspring)
Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey
Time frame: at delivery
DNA methylations measured with 850K-Illumina Infinium assay.
Differentially methylated sites or regions associated with the intervention will be assessed.
Time frame: at delivery
RNA-Seq transcriptome profiling
Up and down-regulated genes associated with the intervention will be assessed
Time frame: at delivery
Body fat (offspring)
Sum of skinfolds measured with a caliper
Time frame: at delivery
Birth weight (offspring)
Time frame: at delivery
Head circumference (offspring)
Time frame: at delivery
abdominal circumference (offspring)
Time frame: at delivery
Length (offspring)
Time frame: at delivery
Number of infants with icterus
Time frame: through hospital admission immediately after delivery
Apgar-score
Apgar score, range from 0-10, with the higher score the better outcome.
Time frame: at delivery
number of patients needing early feeding
Time frame: through hospital admission immediately after delivery
Number of days admitted immediately after delivery
Time frame: through hospital admission immediately after delivery
Number of infants with hypoglycemia
Time frame: at delivery
Weight of placenta
Time frame: at delivery
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